Trial record 2 of 27 for:    Open Studies | "Herpes Simplex"

The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT02045082
First received: January 21, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.


Condition Intervention Phase
Herpes Simplex Keratitis
Procedure: Corneal sampling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Result of the culture [ Time Frame: 1 month after the initial visit ] [ Designated as safety issue: No ]
    The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.


Secondary Outcome Measures:
  • Time before positivity of the culture [ Time Frame: 1 month after the initial visit ] [ Designated as safety issue: No ]
    If the culture is positive for Herpes simplex virus, what is the time lapse(in day) before the culture became positive. The research team will collect the data 1 month in average after the initial visit by examining the microbiologic data of the laboratory.

  • Viral load concentration [ Time Frame: 1 month after the initial visit ] [ Designated as safety issue: No ]
    Quantitative polymerase chain reaction (PCR) will be on a part of the sampling 1 month after the initial visit. The result will be the concentration of virus in number/ml detected in the sampling


Estimated Enrollment: 250
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flocked swab (Copan 519CS01)
Sampling of the cornea by the flocked swab
Procedure: Corneal sampling
Slit lamp corneal sampling with a Swab
Experimental: Traditionnal fiber swab (Copan 164KS01)
Sampling of the cornea by the traditional finer swab
Procedure: Corneal sampling
Slit lamp corneal sampling with a Swab

Detailed Description:

In our center, the flocked swabs became an important tool in the corneal sampling for viral keratitis, replacing rightly or wrongly the former traditional fibers swab. No research was specifically designed to study the corneal taking with these swabs. Nevertheless, numerous reasons would motivate it, because of the peculiarities in ophthalmology: the corneal sampling has to be made with the slit lamp rather than in a macroscopic manner; the corneal lesion are often millimetre-length and confined; the histology of the cornea is unique and compares only imperfectly with other structures of the human body like the nasal mucosa. In these circumstances, the properties of the stalk (rigidity, length) and of its extremity (roughness, textures, absorbance) can influence the quality of the sampling and the final result of the culture.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)

Exclusion Criteria:

  • Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045082

Contacts
Contact: Patricia-Ann Laughrea, MD, CRMC(C) 418-682-7573 palaughrea@orlo.ulaval.ca
Contact: Étienne Laurier, MD Etienne.laurier.1@ulaval.ca

Locations
Canada, Quebec
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec Recruiting
Québec, Quebec, Canada, G1S 4L8
Contact: Patricia-Ann Laughrea, MD, CRMC(C)    418-682-7573    palaughrea@orlo.ulaval.ca   
Contact: Mélanie Ross    418 682-7511 ext 4821    cuo.recherche@fmed.ulaval.ca   
Principal Investigator: Patricia-Ann Laughrea, MD, CRMC(C)         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Investigators
Principal Investigator: Patricia-Ann Laughrea, MD, CRMC(C) Centre de recherche du CHU de Québec; Université Laval
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT02045082     History of Changes
Other Study ID Numbers: DR-002-1399, 2012-1649
Study First Received: January 21, 2014
Last Updated: January 23, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Flocked swab
Traditional fiber swab
Herpes simplex epithelial keratitis
Quantitative PCR

Additional relevant MeSH terms:
Herpes Simplex
Keratitis, Herpetic
Keratitis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Eye Infections, Viral
Corneal Diseases
Eye Diseases
Eye Infections

ClinicalTrials.gov processed this record on July 20, 2014